Tocilizumab plus standard therapy for chronic antibody-mediated rejection after kidney transplant
Official title: Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients With Tocilizumab ,IVIG, Plasmapheresis, Rituximab Versus IVIG, Plasmapheresis , Rituximab
Run by Shahid Beheshti University of Medical Sciences · NCT07006532 · Data updated 2026-11-12
This trial will try adding tocilizumab to standard treatment (plasmapheresis, IVIG, and rituximab) to see if it helps people with chronic active antibody-mediated rejection of a kidney transplant.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Shahid Beheshti University of Medical Sciences Academic / other |
| Drugs / interventions | rituximab, Tocilizumab |
| Locations | 1 site (Tehran) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | January 1, 2027 |
| Study ends | May 1, 2027 |
| Registry record updated | February 11, 2026 |
| Trial ID | NCT07006532 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are kidney transplant recipients with biopsy-proven chronic active antibody-mediated rejection who have eGFR >25 mL/min, chronicity index <8, IFTA <40%, and are EBV IgG positive.
✕Probably not a fit
Patients with active or recurrent infections, abnormal liver function tests, low platelets (<100,000), recent or active malignancy, or very low kidney function (eGFR ≤25 mL/min) are unlikely to benefit or may be excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This open-label randomized trial tests whether adding the IL-6 blocker tocilizumab to standard care (plasmapheresis, IVIG, and rituximab) is safe and more effective for treating chronic active antibody-mediated rejection (CAMR) in kidney transplant recipients. Eligible participants meet biopsy and lab criteria (eGFR >25 mL/min, chronicity index <8, IFTA <40%, EBV IgG positive) and are randomized to receive standard therapy with or without tocilizumab. The study will track donor-specific antibody levels, graft function, and adverse events to determine safety and benefit. The trial is conducted at a single center in Tehran and is open-label.
Why it matters
Potential benefit: If successful, adding tocilizumab could lower donor-specific antibody levels and improve kidney graft survival in patients with CAMR.
How similar studies have gone: Some small case series and early trials of tocilizumab in antibody-mediated rejection have shown mixed signals for reducing donor-specific antibodies or stabilizing graft function, and other approaches like plasmapheresis, IVIG, rituximab, and bortezomib have produced inconsistent results in CAMR.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Signed written informed consent 2. eGFR\> 25 cc/min 3. Chronicity index \<8 4. IFTA\<40% 5. EBV IgG positive Exclusion Criteria: 1. Active or recurrent infections 2. History of malignancy, unless in remission for more than 2 years with no relapse 3. abnormal liver function tests 4. Platelet \< 100,000
Where it's running
-
Nooshin Dalili
Tehran, Iran Recruiting
Study contacts
- Study coordinator: Pi
- Email: dr.nooshindalili@gmail.com
- Phone: 00989122404331
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.